The controversial RU-486 abortion pill, used for more than eight years in France and five years in England, is moving closer to becoming a new method of abortion in the United States.
Facing apparent "fast-track" U.S. Food and Drug Administration (FDA) approval of RU-486, pro-life activists say they will now concentrate their opposition efforts on grassroots education about the drug's potential dangers.
On July 19, an FDA advisory committee recommended that RU-486-known in the United States as mifepristone-be approved as a "safe" and "effective" method of abortion. The drug, when taken along with another medication for several days, induces abortion during the earliest stages of pregnancy without surgery. It is the first chemical abortion method to be considered by the fda in more than 20 years.
FDA Commissioner David Kessler says the recommendation by his agency's Reproductive Health Drugs Advisory Committee was a "very strong signal" that RU-486 should receive final approval for use in the United States within a few months. Because some researchers have suggested that there may be other "therapeutic" uses for RU-486, the FDA has proclaimed it a "priority drug," which will receive swift attention.
POLITICAL IMPLICATIONS:
Pro-life leaders acknowledge that with the advisory committee recommendation, prevention of the drug's entrance into the United States is unlikely. They believe the rapid timetable has the blessing of President Clinton.
"Considering the fast track that the drug has been on, one has to presume that the President wants this thing in the public before the elections," says Olivia Gans, spokesperson for the National Right to Life Committee. "He made that promise to the abortion advocacy groups."
Life Issues Institute consultant Richard Glasow says, "The politicized FDA seems totally incapable of carrying out its statutory responsibility to analyze the scientific and medical data on the safety and efficacy of RU-486."
Mifepristone may only be used during the first seven weeks of pregnancy and requires a combination of drugs for several days. At least two visits to a doctor's office would be required during the procedure, plus follow-up visits. Even if all steps are followed correctly, the pill's manufacturers concede that RU-486 does not successfully induce abortion about 5 percent of the time. In those cases, surgical abortion usually follows.
HEALTH RISK QUESTIONS:
Some physicians have raised concern about the lack of study on the long-term health risks for women taking RU-486, as well as any potential risks for future pregnancies and future children. During testimony before the FDA, Charles Cargille of the Louisiana State University Medical School listed 29 "documented or suspected pharmacological actions" of the drug, which could pose long-term threats to women and children's health.
Cargille and other physicians also have protested the lack of scientific studies on the particular effect of RU-486 on Native American women, as well as on women from Latino, Asian, or African descent. The longest-term studies available have been conducted in England, France, and Sweden, which have significantly lower percentages of these minority population groups than the United States.
Donna Harrison, an obstetrician/gynecologist who works with low-income clients in Michigan, said she is particularly concerned that young women, poor women, and women for whom English is a second language will not be adequately informed about the complicated procedure of an RU-486 abortion or the potential health consequences of the drug. "My patients will be the ones … left to deal with deformed children or hemorrhaging," she says.
AMERICAN STUDIES:
Since October 1994, the Population Council, a nonprofit organization that holds the U.S. patent rights to RU-486, has conducted studies involving 2,100 American women at 17 test sites. According to the council, only a small percentage of women experienced severe complications after using the drug.
However, at least one physician is questioning the accuracy of the U.S. statistics. Mark Louviere, a family practice doctor in Waterloo, Iowa, says he was called to an emergency room in November 1994 to help treat an RU-486 patient who appeared to be "bleeding to death." The woman survived after emergency surgery.
Louviere says he reported the incident to Planned Parenthood, the group administering the RU-486 trial in Iowa. Yet, six months later, Planned Parenthood concluded its clinical testing "with no complications reported among 238 women" who had participated in the local study. "I am concerned that all of the true complications of RU-486 are not being reported to both the media and to the FDA," asserts Louviere, an abortion-rights supporter.
The FDA advisory committee, which recommended RU-486 approval by a 7-to-1 vote, acknowledged that RU-486 is not "risk-free."
Pro-life leaders said they are concerned by recent polls suggesting that doctors who are uncomfortable performing surgical abortions would be willing to prescribe RU-486. "If RU-486 hits the market, it will not just displace some surgical abortions, it will significantly increase the total number of abortions and drive abortion deeper into our social fabric," says Glasow of Life Issues Institute.
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There have been more than 200,000 RU-486 abortions since the drug became legal in Europe.
Pro-life organizations have supported an economic boycott against Hoechst A.G., a German chemical company that is the parent company of Roussel Uclaf, the French manufacturer of RU-486. Hoechst sold the U.S. patent to the Population Council. However, many U.S. pro-life groups still boycott Hoechst, which produces many agricultural products and generic prescription drugs.
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